Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 31901–31920 of 38,428 recalls
Recalled Item: Micro Introducer Kit
The Issue: PFM Medical is recalling catheters and other medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASEPT Pleural Drainage System
The Issue: PFM Medical is recalling catheters and other medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6F x 60 cm Dual Lumen CT PICC
The Issue: PFM Medical is recalling catheters and other medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASEPT Peritoneal Drainage System
The Issue: PFM Medical is recalling catheters and other medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Veta Peritoneal Catheter Kit
The Issue: PFM Medical is recalling catheters and other medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASEPT 600 ml Drainage Kit
The Issue: PFM Medical is recalling catheters and other medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASEPT 2000 ml Drainage Bag
The Issue: PFM Medical is recalling catheters and other medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAS CardioImmune XL Cardiac Marker Control
The Issue: MAS CardioImmune XL, level 1 (lot CXL16011), is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE Calcitonin Control Module (IMMULITE
The Issue: A typographical error regarding the expiration date was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ThermoCool SmartTouch Navigation Catheters
The Issue: The recall was initiated because Biosense Webster is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tenaxis Medical ArterX(TM) Surgical Sealant
The Issue: Product was improperly labeled leading to improper storage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand
The Issue: Laser etching on the parts is wider and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Synthes Mandible External Fixator
The Issue: Under new testing protocols for MR Environment safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand
The Issue: Laser etching on the parts is wider and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand
The Issue: Laser etching on the parts is wider and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INOMAX DSIR Nitric Oxide delivery system
The Issue: An issue has been identified in the INOmax
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand
The Issue: Laser etching on the parts is wider and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti
The Issue: Laser etching on the parts is wider and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand
The Issue: Laser etching on the parts is wider and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand
The Issue: Laser etching on the parts is wider and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.